Completed

Evaluation of Indinavir Sulfate and DMP 266 Activity, Safety, and Pharmacokinetics in Serum Viral RNA Treatment

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What is being tested

Indinavir sulfate

+ Efavirenz

Drug
Who is being recruted

Blood-Borne Infections+13

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorMerck Sharp & Dohme LLC
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

It is hypothesized that after 16 weeks of randomized treatment with either the control or experimental regimen that: The observed proportion of patients with serum viral RNA < 400 copies/ml in the experimental and control regimen will be similar and will continue to be so after 48 weeks. The safety profiles of the two groups will be similar, judged by the incidence of serious, drug-related adverse experiences and the incidence of events of specific interest (e.g., nephrolithiasis, hyperbilirubinemia, nausea/vomiting, rash, and CNS-related symptoms) and will continue to be so after 48 weeks. The two groups will be similar with respect to changes from baseline in serum viral RNA and CD4 counts and will continue to be so after 48 weeks. Patients are randomized to one of two regimens: a control regimen of indinavir plus DMP 266 or an experimental regimen of indinavir plus DMP 266, each at different doses than in the control regimen.

NCT00002387
Principal SponsorMerck Sharp &amp; Dohme LLC
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV Infections

Criteria

3 inclusion criteria required to participate
CD4 count >= 100 cells/mm3
HIV-1 seropositive status
Serum viral RNA levels >= 10,000 copies/ml
2 exclusion criteria prevent from participating
Prior non-nucleoside reverse transcriptase inhibitor therapy
Prior protease inhibitor therapy

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 8 locations

UCSD Treatment Ctr / Dept of Medicine & Pediatrics

San Diego, United StatesOpen UCSD Treatment Ctr / Dept of Medicine & Pediatrics in Google Maps

San Francisco Gen Hosp

San Francisco, United States

Univ of Colorado / Health Science Ctr

Denver, United States

Hawaii AIDS Clinical Trial Unit

Honolulu, United States
Completed8 Study Centers